Cleared Traditional

K160623 - FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture

K160623 is an FDA 510(k) clearance for FILASILK - Natural Non-absorbable Silk ..., manufactured by M/s. Meril Endo Surgery Private Limited.. The device is a Class 2 General & Plastic Surgery device with product code GAP cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K160623 · M/s. Meril Endo Surgery Private Limited. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
88d
Days
Class 2
Risk

K160623 is an FDA 510(k) clearance for the FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorb.... Classified as Suture, Nonabsorbable, Silk (product code GAP), Class II - Special Controls.

Submitted by M/s. Meril Endo Surgery Private Limited. (Chala, Vapi, IN). The FDA issued a Cleared decision on May 31, 2016 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5030 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all M/s. Meril Endo Surgery Private Limited. devices

FDA 510(k) Submission Details - K160623

510(k) Number K160623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2016
Decision Date May 31, 2016
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAP Device Classification - Class 2, Special Controls

Product Code GAP Suture, Nonabsorbable, Silk
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAP Suture, Nonabsorbable, Silk

All 25
Devices cleared under the same product code (GAP) and FDA review panel - the closest regulatory comparables to K160623.
SafePath Suturing System
K180701 · Safepath Medical, Inc. · Jun 2018
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture
K172149 · M/s. Meril Endo Surgery Private Limited. · Oct 2017
SILK Surgical Suture
K162396 · Teleflexmedical, Inc. · Nov 2016
NON-ABSORBABLE SILK SUTURE
K071111 · Arrow Intl., Inc. · Jul 2007
TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE
K041514 · Sutures India Private Limited · Jun 2005
UNISILK
K042282 · United Medical Industries Co. , Ltd. · Dec 2004